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Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio.
Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.
Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure.
The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.
Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.
Tegoprubart, Eledon Pharmaceuticals’ experimental anti-CD40L antibody, was part of the immunosuppressive treatment regimen used following the first-ever transplant of a kidney from a genetically modified pig to a human.
Oprah Winfrey this week shone the spotlight on these transformative GLP-1 medications. Now, it’s time for Medicare to cover them and expand access to millions of Americans.
Duvyzat, which will be sold in the U.S. by ITF Therapeutics, joins a growing market that includes recently approved gene therapy Elevidys and corticosteroid Agamree.
At Thursday’s Pharma Media Day, Bayer touted Nubeqa as the fastest growing androgen receptor inhibitor in the U.S., which will achieve blockbuster status this year.